Abbott Announces “Medical Device Correction” Due to Seven Deaths and Serious Health Complications in Connection With Malfunctioning Glucose Monitors

WASHINGTON — Federal health officials are warning millions of users about a safety issue involving specific Abbott Diabetes Care glucose sensors after reports surfaced of severe adverse events and several potential deaths.

Abbott announced a “medical device correction” for select FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, and the U.S. Food and Drug Administration later issued an early alert, a notice used when a company begins correcting or removing a product that may pose significant safety risks before a formal recall determination is made.

Affected sensors may display inaccurate low glucose readings. These incorrect readings can lead users to adjust their treatment based on false information, such as skipping insulin doses or consuming excess carbohydrates, which may cause dangerously uncontrolled blood sugar levels.

Health authorities warn that mismanaged glucose levels can result in serious complications, including diabetic ketoacidosis, cardiovascular events, stroke, organ damage, or infection, and in severe cases, may lead to death.

Abbott has received 736 reports of severe adverse events worldwide, including seven deaths outside the U.S., that may be linked to the malfunctioning sensors.

Only specific FreeStyle Libre 3 and Libre 3 Plus sensor models are affected.

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